Pfizer stops development of an investigational drug to treat obesity

HQ Team

April 15, 2025: Pfizer Inc. stopped its trial of danuglipron for treating chronic weight management after an asymptomatic patient developed a drug-induced liver injury that was resolved after discontinuation of the oral drug.

Trials on once-daily formulations of danuglipron met key pharmacokinetics objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in end-stage testing, based on earlier studies of twice-daily danuglipron, according to a statement.

“While the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury,” the company stated.

That was resolved after the discontinuation of danuglipron.

‘Continue research’

“After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer has decided to discontinue development of the molecule.”

Pfizer would continue research to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care, including continued development of its oral GIPR antagonist candidate and other earlier obesity programs, said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research and Development at Pfizer.

An oral GIPR (glucose-dependent insulinotropic polypeptide receptor) antagonist candidate is a type of drug designed to block the GIP receptor, which plays a role in metabolic regulation, obesity, and diabetes.

GIPR antagonists work by inhibiting the GIP receptor, which is involved in promoting lipid storage and metabolic regulation. Blocking this receptor can help reduce weight gain and improve metabolic health, especially when combined with GLP-1 receptor agonists.

‘Unmet medical need’

“Cardiovascular and metabolic diseases, including obesity, remain important areas of unmet medical need,” Boshoff said.

“While we are disappointed to discontinue the development of danuglipron, we remain committed to evaluating and advancing promising programs to bring innovative new medicines to patients.”

Data from the danuglipron clinical development program will be presented at a scientific forum or submitted for publication in a peer-reviewed journal in the future, according to the Manhattan-based company’s statement.